Anterior Cruciate Ligament InjuriesNCT05893875
Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment
An observational study of Anterior Cruciate Ligament Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2021to 28 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who underwent anterior cruciate ligament reconstruction surgery at the Sports Medicine Department of Sun Yat sen Memorial Hospital and required joint effusion extraction due to postoperative treatment
Who may be able to join
- Those with healthy diet and regular exercise habits;
- Sports injury patients(Satisfy one of the following conditions): Anterior cruciate ligament injury or meniscus injury
Who cannot join
- Existence of underlying diseases related to the immune system;
- Trauma leading to knee joint fracture;
- Blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal;
- Significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases;
- Patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yatsen Memorial Hospital
Guangzhou, Guangdong, 510120
Hua M Peng, +86 15626263951, penghm5@mail2.sysu.edu.cn
About this study
This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.
Read the detailed description
This study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from January 2021. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. The indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: Lysholm scale, VAS scale, and Tegner scale. Among them, the Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery; The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain; The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery.
- Conditions
- Anterior Cruciate Ligament Injuries
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Score for pain (VAS)
The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain;
Measured: Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation
Lysholm score
The Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery;
Measured: Change from 6 months and 1 Year after ACLR operation
Tegner sacle
The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery
Measured: Change from 6 months and 1 Year after ACLR operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start31 Jan 2021
- Primary completion28 Dec 2023 (estimated)
- Study completion28 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893875
- Sponsor's protocol ID
- SYSKY-2022-553-01
- Status last verified
- May 2023
- First submitted
- 27 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment
- ClinicalTrials.gov ID
- NCT05893875
- Acronym / sponsor ID
- SYSKY-2022-553-01
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 28 Dec 2023 (estimated)
- Study completion
- 28 Dec 2023 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.
Detailed description
This study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from January 2021. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. The indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: Lysholm scale, VAS scale, and Tegner scale. Among them, the Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery; The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain; The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who underwent anterior cruciate ligament reconstruction surgery at the Sports Medicine Department of Sun Yat sen Memorial Hospital and required joint effusion extraction due to postoperative treatment
Key inclusion criteria (2 listed)
- Those with healthy diet and regular exercise habits;
- Sports injury patients(Satisfy one of the following conditions): Anterior cruciate ligament injury or meniscus injury
Key exclusion criteria (5 listed)
- Existence of underlying diseases related to the immune system;
- Trauma leading to knee joint fracture;
- Blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal;
- Significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases;
- Patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Score for pain (VAS)
Time frame: Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation
The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain;
Lysholm score
Time frame: Change from 6 months and 1 Year after ACLR operation
The Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery;
Tegner sacle
Time frame: Change from 6 months and 1 Year after ACLR operation
The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score for pain (VAS) (time frame: Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.